Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
NCT ID: NCT01708629
Last Updated: 2020-01-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1881 participants
INTERVENTIONAL
2012-09-30
2015-10-31
Brief Summary
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A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.
A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
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Detailed Description
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A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.
A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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210 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
210 mg brodalumab
210 mg brodalumab administered SC
140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
140 mg brodalumab
140 mg brodalumab administered SC
ustekinumab
Administered by subcutaneous (SC) injection per the labeled dosing regimen.
ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
Placebo
Administered by SC injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
210 mg brodalumab
210 mg brodalumab administered SC
placebo
placebo administered SC
Interventions
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210 mg brodalumab
210 mg brodalumab administered SC
140 mg brodalumab
140 mg brodalumab administered SC
ustekinumab
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
placebo
placebo administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline
Exclusion Criteria
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has not stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Beverly Hills, California, United States
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Burbank, California, United States
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Encino, California, United States
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Fremont, California, United States
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Fullerton, California, United States
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Irvine, California, United States
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Los Angeles, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Trumbull, Connecticut, United States
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Boca Raton, Florida, United States
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Coral Gables, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Tamarac, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Boise, Idaho, United States
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Arlington Heights, Illinois, United States
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Champaign, Illinois, United States
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Maywood, Illinois, United States
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Normal, Illinois, United States
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Wheaton, Illinois, United States
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Indianapolis, Indiana, United States
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New Albany, Indiana, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Clarkston, Michigan, United States
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Clinton Township, Michigan, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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East Windsor, New Jersey, United States
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Hoboken, New Jersey, United States
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Verona, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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High Point, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Lake Oswego, Oregon, United States
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Portland, Oregon, United States
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Exton, Pennsylvania, United States
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Johnston, Rhode Island, United States
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Greer, South Carolina, United States
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Bartlett, Tennessee, United States
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Nashville, Tennessee, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Webster, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Clarksburg, West Virginia, United States
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Camperdown, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Kogarah, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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Hectorville, South Australia, Australia
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Fremantle, Western Australia, Australia
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Bruges, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Montigny-le-Tilleul, , Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Markham, Ontario, Canada
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Richmond Hill, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Drummondville, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Hyacinthe, Quebec, Canada
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Créteil, , France
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Limoges, , France
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Nice, , France
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Poitiers, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Chaïdári, Athens, Greece
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Athens, , Greece
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Ioannina, , Greece
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Larissa, , Greece
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Marousi, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Gyula, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Szombathely, , Hungary
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Bologna, , Italy
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Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Roma, , Italy
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Roma, , Italy
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Ventspils, , Latvia
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Bialystok, , Poland
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Dąbrówka, , Poland
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Gdansk, , Poland
Research Site
Iwonicz-Zdrój, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Stalowa Wola, , Poland
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Świdnik, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Yekaterinburg, , Russia
Countries
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References
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Lebwohl MG, Armstrong AW, Alexis AF, Lain EL, Jacobson AA. Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses. Dermatol Ther (Heidelb). 2024 Oct;14(10):2709-2726. doi: 10.1007/s13555-024-01264-3. Epub 2024 Sep 12.
Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120104
Identifier Type: -
Identifier Source: org_study_id
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